Recurrent or metastatic head and neck squamous cell carcinoma
Conditions
Interventions
Experimental group:Camrelizumab combined with Fluorouracil and Cisplatin
Sponsors
Affiliated Cancer Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with recurrent or metastatic head and neck squamous cell carcinoma (except nasopharyngeal carcinoma) confirmed by pathology or clinical diagnosis and not suitable for surgery; 2. Patients who have not received systemic treatment in the past; 3. Patients with known PD-L1 expression before enrollment; 4. Patients with measurable tumor lesions (spiral CT scan >= 10mm, meeting RECIST 1.1 standard); 5. Patients with expected survival time > 3 months; 6. Age: 18 to 70 years old, no gender limit; 7. ECOG PS: 0-2 points; 8. The damage caused by the patient receiving other treatment has recovered; 9. The functions of vital organs meet the following requirements: a) Absolute neutrophil count >= 1.5 x 10^9/L, platelet >= 100 x 10^9/L, hemoglobin >= 9g/dL; b) Bilirubin 35g/ml, prothrombin time extension 60 mL/min; 10. Women of childbearing age must have a negative pregnancy test (ßHCG) before starting treatment, and women and men of childbearing age (have sex with women of childbearing age) must agree to use effective contraceptive measures without interruption for 6 months after the last dose of treatment during treatment; 11. The patients volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with other malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 2. Patients with bone marrow suppression or coagulation disorders and patients with renal impairment; 3. Patients with active tuberculosis infection. Patients with active pulmonary tuberculosis infection within 1 year before medication should be excluded even if they have been treated. Patients with a history of active pulmonary tuberculosis infection more than 1 year ago should also be excluded, unless it is proven that they have previously received standard anti-tuberculosis treatment; 4. Patients with active hepatitis B or C, and chronically infected patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) with a viral load of less than 2000 IU/mL are allowed to participate in the study, but are required during the study period Continue or start the full course of standardized antiviral therapy; 5. Patients with active, known or suspected autoimmune diseases, hypothyroidism that only needs hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or hair loss) can be selected; 6. Patients with congestive heart failure, uncontrollable arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months; 7. Patients receiving hematopoietic stem cell or organ transplantation; 8. Patients who have been vaccinated or are about to be vaccinated with live vaccines within 30 days before the administration of Carrelizumab; 9. Pregnant or lactating women; 10. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up; 11. Patients with a history of psychotropic drug abuse, alcohol or drug abuse; 12. Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive; 13. Patients considered by the investigator to be inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;OS;PFS; | — |
Countries
China
Contacts
Public ContactChuncheng Hao
Affiliated Cancer Hospital of Harbin Medical University
Outcome results
None listed